Extracorporal thermo-therapy device and method for curing diseases

ABSTRACT

This invention is an extracorporal thermo-therapy device having inlets and outlets being connected in shunt to a human body&#39;s blood vessel system, thereby providing the blood with a detour outside the body, thus becoming an integral part of the body&#39;s circulatory fluid system. The fluid system includes not only the blood itself but also all other body fluids (through the intra-corporal exchange between the blood and all other body fluids) for example the serum from the lymphatic system. The purpose of the invention is to use the process and device described to generate extracorporal fever in the blood to a level of around 2 C. above normal body temperature everytime it is on said detour, thus activating the body&#39;s own immune system by stimulating the production of white blood cells and antibodies. If the device is used to generate extracorporal fever to a level of around 2 C. above high fever body temperature in the blood everytime it is on said detour, the purpose of the apparatus and process described is to act as an Attenuator repeatedly combating viruses with the ultimate purpose of becoming an assassin and annihilating them. The blood can be allowed to enter into the body at a low fever temperature, in order to stimulate the body&#39;s immune system in vivo. Many people have been identified by diagnosis as being infected by AIDS. In such people AIDS is in most cases dormant: they do not have the symptoms of the disease but they are infectious carriers of the AIDS virus and therefore a danger to others. People who are carriers of the AIDS virus but are not victims of the symptoms are in fact more dangerous to mankind than the victims of the symptoms, as their contact with people is not controlled and their number is many times higher. However, the invention combined with additional features and medicaments does facilitate the curing of serious diseases such as AIDS, at a fully developed stage, and also malignant cancer tumors. This extracorporal thermo-therapy method involves a continuous and persistent process, and so will have a greater effect than an intermittant treatment, for example a batch process, because--according to the invention--the unwanted viruses and unwanted cells will not be allowed the opportunity to strengthen, multiply, and reattack. The invention with the additional features and medicaments is described.

CROSS REFERENCE TO RELATED APPLICATION

This application is a division of Application Ser. No. 837,688, filedMar. 10, 1986, now U.S. Pat. No. 4,787,883.

BACKGROUND OF THE INVENTION

It is well-known that man is gifted with a system to prevent or overcomediseases. It is the human immune system which reacts against almost everoutside influence. If the diseases are caused by weaker bacteria andviruses, the body defends itself using its immune system. Man is notalways aware of such a reaction as it does not involve a noticeable risein the body temperature. It is believed that the body's built-in immunesystem even reacts against some medicaments administered to the body,for instance antibiotics sometimes cause allergic reactions and have tobe withdrawn and are therefore not given the chance to cure which theyhave proved that they can do in test-tubes (in vitro). Another type ofreaction by the immune system occurs when the body is exposed to outsidetemperatures from, for example 20° C. to sauna temperatures of more than50° C. then the immune system reacts to keep the body's temperaturenormal. However, the body does raise its temperature to several degreesabove the normal 37° C. to combat certain bacteria and viruses. Duringsuch a rise in temperature (fever), there is a simultaneous productionof a higher number of white blood cells, including lymphocytes, or anincrease in the power of the existing white blood cells. Such areinforcement in the strength of the white blood cells is an importantpart of the natural curing process.

However, there are viruses today which behave in a very different waythan normal viruses. AIDS viruses, for example, seem, in one way oranother, to make the human immune system collapse instead of formingantibodies and vaccines. Therefore it is here believed that AIDSinfected patients do not, as a rule, die from the attack by the AIDSvirus itself but from other infections because their immune systems havebeen inactivated by the AIDS virus.

Various types of cancer are notoriously incurable, they multiply theircells to form malignant tumours. Surgery, x-rays and high-voltagetreatment have been used alone or in combination with variousmedicaments in chemotherapy treatment, however not always with theexpected success. For mankind cancer is still a major cause of death.

It is necessary to find other ways of preventing unwanted viruses andcancer cells from being deadly for man.

It is well-known that virus, per se, is labile, notoriously unstable, toeven modest temperature increases (i.e. from 37° C. to for example 41°C.). The same instability to temperature also applies to many malignanttumor syndromes--cf, for example, the successful hypothermical treatmentof various highly localized bladder cancerous cases (44/45° C. watertreatment of the interior of the bladder).

Virus and tumor cells are severely attenuated by a sudden shift intemperature (for example from 37° C. to 42° C.). These findings havebeen demonstrated by many investigators during the last 10 years, viacell culture experiments (in vitro). For example, it has beendemonstrated--by in vitro test-tube experiments--that viruses do notmultiply at their usual 37° C. rate when exposed to temperatures of 41°C. (i.e. a 40% reduction of the infectious virus particle was achieved).

A 40% reduction in the ability of a virus to multiply with a rise intemperature of only 3°-4° C. is remarkable. The successful hypothermicaltreatment of bladder cancers is equally important.

Well-known institutes working in the field of cancer research, incooperation with hospitals, have published their findings afterobserving several cases of cancer: malignant cancer tumors completelydisappeared in persons who developed a severe fever such as that causedby malaria or smallpox.

Several years ago Dr. Kr Overgaard et al., in cooperation with theresearch institute for cancer (Kraeftforeningens forskningsinstitut) inAarhus, Denmark, demonstrated in mice the reaction of cancer tumors to arise in temperature. A temperature between 41° and 43° . was created bydiathermy. In each case the whole mouse was exposed to the temperaturefor more than an hour. In 75% of the cases the mice did not survive therise in temperature. However, in 25% of the cases the mice did surviveand the cancer tumors disappeared totally.

An observation made by hospitals seems to be important as it is relatedto fever situations: If a man is the victim of a coronary infarct hedevelops (without the presence of any known infection) a fever of about39° C. 12-24 hours after the attack. A remarkable rise in the number ofwhite blood cells occurs subsequent to the fever.

These findings underline the fact that the white blood cells eitherincrease in number and/or in strength when exposed to temperaturesslightly higher than the normal body temperature.

Viruses and cancer cells have a common enemy: a rise in temperature.AIDS viruses and cancer cells are killed or at least severely attenuatedat temperatures between 41° C. and 45° C. Low fever stimulates theproduction of white blood cells and antibodies.

The blood, as it circulates around the body, constantly exchangessubstances with the lymph and all other body fluids. The result of thisprocess of exchange has an influence on the spleen, kidneys, heart,liver, marrow, etc, and vice versa. The exchange of lymph, blood and allother body fluids is achieved by osmosis through diffusion and othermore direct types of mixing. For example the thoracic duct daily emptiesabout 2 liters of lymph into the veins of the blood at the junction ofthe left internal jugular and subclavian veins.

Diminutive quantities of casual intakes of liquid or food, contaminatedwith heavy metals like lead or mercury, can be measured not only in theblood and bones, but also in the hair. These findings prove that theblood even has an influence on such parts of the body which containhardly any blood or other body fluid themselves.

SUMMARY OF THE INVENTION

This invention of an extracorporal fever device can be described as ashort-term `bombardment`, involving in vitro fever each time the bloodpasses through the extracorporal device. The fever being producedoutside the body might, in some cases, be at a temperature in theextracorporal device which is not acceptable in vivo.

As explained in the beginning of the description of the invention below,an aspect of this invention is that it has the ability to combatviruses, for example AIDS viruses, which have been diagnosed as beingpresent in a person's blood at an early--unsymptamatic--stage, therebycuring a person who is a danger to other people.

If the invention is combined with other features and medicaments, asdescribed later, the extracorporal device can combat more seriousdiseases, that is diseases further developed (with symptoms) because ofAIDS viruses and, for instance, maligant cancer tumors.

Extracorporal devices, for example those used as artificial kidneys, arein daily use all over the world and have probably saved and prolongedthe lives of hundreds of thousands of people.

An interesting link has been observed by nephrologists betweenextracorporal renal dialysis and the absence of AIDS. The followingeditorial letter (from David N Edelbaum, MD, FACP) appeared in The NewEngland Journal of Medicine: No AIDS Among Patients on Dialysis?--"Ihave been intrigued by the apparent rarity of the acquired immunodeficiency syndrome (AIDS) in the dialysis population. One would expectthat in such a population--whose members have been invaded by needlesand frequent transfusions for many years and have been in a chronicstate of immunosuppression--the incidence of AIDS would be much higherthan in the general population. The incidence of hepatitus--classic andother forms--is as well documented as those of other viruses--e.g.,cytomegalovirus--and all patients on dialysis seem to be susceptible toalmost every other infection possible. I have asked many of mynephrologist colleagues about their experience, and they agree that AIDSis almost unheard of in this population. . . . "

If an extracorporal device, used in the treatment of kidney diseases, isable to prevent the development of diseases such as AIDS, then it iseasier to understand that this thermo-therapy invention, with itsspecial features including the use of a certain temperature range tostimulate the formation of white blood cells and antibodies, andanother, higher, temperature range for the killing of viruses andunwanted cells, and special devices to administer chemotherapeuticals,all working in unison during the blood's regulated reaction time, hasthe ability to cure.

The invention below described is an extracorporal device, however notonly is it used in a very different extracorporal way than those used asartificial kidneys or as heart/lung machines, but its construction isalso very different as described below.

One aspect of this invention is its ability to cure diseases byconnecting an extracorporal thermo-therapy device to the blood vessels,thus providing an extension of the blood's circulatory path by way of adetour through the extracorporal device. This process of passing theblood through the extracorporal device to be repeated as much as up to ahundred times a day, or as little as less than a hundred times a weekduring the treatment period, combating the viruses and unwanted cellsagain and again.

This extracorporal device, when used to combat unwanted bacteria,viruses and cancer cells, makes it possible to employ a method whichdoes not destroy the body's own immune system but maintains and evenenhances it, thereby assisting the immune system in its attack againstdisease.

This apparatus here described can be called an extracorporalthermo-therapy device providing the before-mentioned detour of the bloodfrom its natural circulatory route. While the blood is making suchdetour it is given an artificial fever treatment. A temporary rise inthe temperature of the blood, generated in the extracorporal device,could be 3°-4° C. above a normal body temperature or even severaldegrees higher than the temperature the body itself can tolerate.

The tendency blood has to coagulate at high temperatures is prevented byadding anticoagulation substances like Natriumnitrate, Heparin, Dextran,etc. Dextran will dilute the viscosity of the blood and, with anaddition of saltwater, will secure more distance between the blood cellsand the blood plates. Such anticoagulants must be added in quantitiessufficient for non-coagulation of the blood at increased temperatures.The anticoagulation effects of Heparin, for example, might be reducedwith the right amount of products like proteminosulphate and/or vitaminK, before the blood re-enters the body.

The extracorporal device contains a cooling device which can lower thetemperature of the blood to an acceptable body temperature everytime itre-enters the body. Such a temperature could be a few degrees higherthan the normal body temperature, thus the blood heated in theextracorporal device creates a fever in vivo thereby enhancing thestimulation of white blood cells and antibodies.

The choice of time and temperature depends on the disease. For example,if during the first hours or days of treatment it is the aim of theextracorporal device to improve the immune system, then the blood willbe passed through the detour at a temperature of around 39° C. for aperiod of time. Once the immune system has improved, the temperature canbe increased to one which would attenuate and kill viruses. However, ifthe aim of the extracorporal device is to start immediately with thecombating of viruses and unwanted cells, then a higher temperature willbe selected when the treatment commences. Once a cure has been set inmotion, the temperature can be lowered several degrees to one whichwould improve the immune system.

The extracorporal device allows for a choice to be made in thetemperature--for example 3 days at a temperature of 39° C. and 3 days ata higher temperature of 43° C. In addition the device allows for suchsequences of temperature to be repeated several times, depending on howfar the cure has progressed.

The device, in accordance with the invention and the method inaccordance with the invention, is in one special embodiment executed insuch a way that the blood coming from the veins of the person isseparated so that one portion of the blood contains the majority ofwhite blood cells plus serum, while the other portion of the bloodcontains predominently red blood cells plus serum. This separationenables the blood which contains mostly white blood cells to have adifferent treatment in time and in temperature compared to the one whichthe other portion of the blood receives at the same time. The advantageof such a separation is that it is possible to keep the blood containingthe white blood cells outside the body for a longer time and at atemperature of, for example, 39° C., thus improving the white bloodcells' power and the blood's immune system. The portion of the bloodwhich contains more red blood cells might be treated with a highertemperature, for instance a temperature in the order of 42°/43° C.

The temperature range which preferably should be used in theextracorporal devices where the blood is running in a single detour or aparallel detour is from about 2° C. higher than normal body temperatureto a degree around 2° C. higher than high fever body temperature.

It is to be understood that in one embodiment the invention, asdescribed, has a battery of several extracorporal reactor devices to beshunted in or out, thereby making it possible to run the equipment withdifferent blood temperatures. In this way it is possible to have adetour with a blood temperature of, for example, 39° C. in some of thereactors and to have a temperature of, for example, above 40° C. inother reactors of the extracorporal device.

In one embodiment of the invention a reactor can is involved in theprocess. The purpose of the reactor can is to prolong the treatmentperiod of the blood or part of the blood. The can is preferablypositioned after the extracorporal device so that the blood passesthrough the extracorporal device and the reactor can successively,before re-entering the body. The level in the reaction can to beregulated by keeping the can more or less filled up with blood, forexample from 100 ml to 1 liter or more.

In another special embodiment of the reactor can, the can has platesplaced from the top of the can from one side to another. The first plateis fastened to one side of the can in a declining position, not touchingthe other side of the can. The next plate is placed in a decliningposition opposite the first plate and is connected to the other side ofthe can. This plate system is repeated several times in a downwarddirection in the can. The plate system in the can is intended to improvethe oxidation of the blood, by running it in thin layers over theplates. The can and its plates will also ensure that the blood whichenters the reaction can first will also leave first, via the bottom ofthe can.

In the above-mentioned reactor can chemicals, pharmaceuticals,antidotes, protein sulphate, etc, can be checked and regulated to themaximum level for the patient and his disease. In the reactor can it isalso possible to regulate the temperature of the blood, according towhich of the following treatments are to be employed: the enhancing ofthe immune system and/or the combating of viruses and unwanted cells.

Virus-attenuating pharmaceuticals can also be added, according to theinvention, while the blood is on its detour through the extracorporaldevice and the reaction can. An example of such a pharmaceutical isFormaldehyde which is added, via the extracorporal device, to the bloodin very small quantities (preferably in vapour form) while it is on itsdetour. Formaldehyde can be dangerous when added to the human bodyitself, however it is not dangerous when added in such small quantitiesto the blood in vitro. The Formaldehyde is use in vitro to changedangerous viruses into corresponding vaccines. Formaldehyde changespoisonous toxin into antoxin thereby keeping or even producing activeantibodies in the blood.

It is possible to operate the reaction can in such a way thatultraviolet light or light of the wavelengths of natural sunshine can bedirected to the blood while the blood is splashing from one of the can'sdeclining plates to another. Ultraviolet light is a killer or attenuaterof many viruses. Ultraviolet light can be exposed to a higher quantityof blood in the reaction can than sunshine is by reaching a person'sskin. Ultraviolet light is used for attenuating and/or killing virusesto produce vaccines, for instance against poliomyelitis.

The administration of certain very active pharmaceuticals is apossibility because antidotes and other neutralising agents can be usedto reduce the level of pharmaceuticals to a level which will not causeharm to the body, before the blood re-enters the body. In this way theblood receives a treatment outside the body from which the patientbenefits in vivo.

It is here believed that another advantage of keeping a portion of theblood, for instance half a liter or more, out of the body while it is onthe detour through the extracorporal device, is that this process,independent of any other treatment the blood receives on the detour,will improve the blood's ability to heal. This belief follows the theoryof phlebotamy by which the newly-formed blood cells and antibodies etcare of a "quality" superior to those which have been temporarily takenout. This blood-letting system, combined with the invention's low-fevermethod, enhances the body's immune system.

When the treatment period is over, after hours or weeks, the bloodcontained in the extracorporal device and the reactor can might go backto the body via a small osmotic dialysis unit which is used to remove asurplus of water and other substances in accordance with the opinion ofthe medical supervision. An alternative way to remove a surplus of wateris to administer diuretics.

Using diathermy to heat the blood passing through the extracorporaldevices is an alternative to heating the blood using water or otherliquids surrounding the blood contained in the extracorporal devices.Diathermy is supposed to minimise blood clotting or adherence to theapparatus.

An instantly-working analysis equipment connected to the extracorporaldevice and to the body, monitors the effect of the treatment on thepatient's general condition, in the first instance to evaluate howstrong a treatment (temperature, time, medicaments, etc.) the patientcan tolerate, in order to bring about a cure as soon as possible and inthe second instance to correct any undesired effect on the patient'scondition.

As mentioned before, temperatures around 39° C. are mainly for improvedformation of the body's antibody and immune system, and temperaturesabove 40° C. are mainly for attenuating, by repeatedly combating virusesand unwanted cells and bacterias until they have been annihilated.

The vital organs of the human body benefit from the treatment which theblood receives on its detour, because they are connected to the body'scirculatory system of which the extracorporal device, according to theinvention, is an integral part. Everytime the blood returns to the vitalorgans the blood has improved in quality, and thereby in its ability tocure.

It is obvious that a greater effect will be obtained by using acontinuous extracorporal themos process, according to the invention,rather than a process which is discontinued, i.e., a batch process.

Therefore, it is an object of the invention that not enough time shouldbe allowed for already attenuated viruses and unwanted cells to recoveror multiply. These invaders should be attacked again and again until acure is achieved.

DESCRIPTION OF THE DRAWINGS

FIGS. 1-4 show four preferred embodiments of extracorporal apparatusaccording to the present invention when connected to a patient, and

FIGS. 5a-5c show alternative elements which can be used in the inventiveextracorporal apparatus.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a first preferred embodiment of extracorporal apparatusaccording to the present invention. It includes a connector 1 which isconnected to a patient's blood vessel, a pump 2, an extracorporal devicedetour reactor 3, which is heated by means 4, being equipment fordiathermy heating, or else, a fluid system 5 for raising the bloodtemperature on its detour. The blood continues through another pump 6,which for pulsation purposes may be out of rhythm with the pump 2. Fromthe pump 6 the blood passes a filter 7, which prevents possibly cloggedparticles of the blood re-entering the body, and then back into thepatient at connector 8.

FIG. 2 shows a second preferred embodiment of the invention. It includesa connector 9 which is connected to a the patient, separator 10, forseparating the blood supplied thereto from connector 9 into twoportions--one being richer in red blood cells and the other being richerin white blood cells. From the separator, one outlet of the blood ispassed through a pump 11 to the extracorporal device detour reactor 12,which is heated by surrounding liquid 13. The other portion of the bloodfrom the separator 10 is passed throug another pumping system 14 fromwhich it is led to a parallel extracorporal device detour reactor 15,heated by surrounding liquid 16. The two portions of the blood are boththen led to a filter 17, before the blood re-enters the patient's bloodvessels via connector 18.

FIG. 3 shows a third preferred embodiment of the present invention. Itincludes a connector 19 connected to a patient's blood vessel, which isconnected to a tubular system 20 which leads the blood stream to one orseveral of the battery of reactors 21, heated by electricity, preferablydiathermy 22 through tubes with fittings 23 which enable the insertionof several reactors to keep the blood on its detour for an extendedtime. A fitting 24 connects the blood to a pump 25. The blood passesthrough a filter 26 and then returns to the veins of the patient at 27.

FIG. 4 shows a fourth preferred embodiment of the present invention. Itincludes a connector 28 which is connected to a flow circuit whichincludes patient's blood vessel, a series of supply bottles 29 foradding various medicaments, pharmaceuticals and chemicals includingInterferon and Interleukin, etc., to the flow of blood, before it entersa tubular detour. Comprising a heating container 30. Other heatingcontainers 31 can be shunted in or out depending on the desired reactiontime. A heating system 32 is employed to control the temperature rise ofthe blood in the detour reactor and a connection 33 extends between theand a reaction container 35 to which it is possible to add othermedicaments which may increase or reduce the effect of the medicamentsadded by supply bottles 29. The reaction container 35 retains a portionof the blood to increase the reaction time and has plates to make theblood pass in thin layers if desired. Supply bottles 34 can be used toadminister pharmaceuticals, chemicals and/or antidotes to the blood. Thereactor 35 can be open or closed reaction container as desired. Adialysis column 36 can be used, according to the invention, to clean theblood after the blood has passed a filter (not shown on this drawing).From the dialysis column the blood enters an instantly-working analysisequipment or monitor 37 to check the condition of the blood on itsdetour, and the condition of the patient, and then the blood enters apumping and pulsator system 38 from where the blood, now treated,re-enters the body of the patient at connector 39. From the pumpingsystem 38 there is another possible outlet through a valve system, alsocontained in 38, through a tubular system 40, which can deliver aportion of the treated blood to another part of the patient's body.

FIGS. 5a-5c are to be understood in relation to FIGS. 1, 2, 3, 4 and thecorresponding explanation of these figures. However, FIG. 5a-5cillustrate embodiments of the invention, which are neither toocomplicated to administer in medical care, nor too inconvenient for thepatient. In these Figures valves, pumps, analysis equipment, medicamentsupply, are not shown.

FIG. 5a shows one of the preferred embodiments of the invention: Theblood enters a dialysis osmosis apparatus 41 of the type conventionnalyused as artificial kidneys. However, in accordance with the invention,pharmaceuticals and chemicals are to be administered through an osmosisprocess into the blood, i.e., the dialysis liquid surrounds the tubes inthe dialysis equipment, thereby delivering the pharmaceuticals andchemicals to the blood. FIG. 5b shows the thermo-therapy reactor 42,itself heated by diathermy or liquid such as water.

FIG. 5c shows a second dialysis device 43, which through osmosis--orreverse osmosis removes, regulates or controls the blood and themedicaments added, before the blood re-enters the body of the patient.

A raised temperature in the dialysis equipment 41 and 43 adds reactiontime, if preferred, to the blood beyond the reaction time secured in thereactor 42.

I claim:
 1. An extracorporal thermo-therapy apparatus for use incontinuously treating the blood of a patient for disease, saidextracorporal apparatus comprising:first connector means for removing aflow of blood from a patient, second connector means for returning saidflow of blood to said patient, and a flow circuit connected between saidfirst connector means and said second connector means, said flow circuitincluding:a heating means for raising the temperature of said flow ofblood so as to stimulate its production of white blood cells andantibodies and attenuate or kill viruses and undesired cells therein, afirst supply means for adding treatment chemicals to said flow of bloodbefore it enters said heating means, a second supply means for addingadditional treatment chemicals to said flow of blood after it leavessaid heating means, and a pumping means for moving said flow of bloodthrough said flow circuit.
 2. The extracorporal thermo-therapy apparatusaccording to claim 1, wherein a first flow tube extends from said firstconnector means to said heating means, and wherein said first supplymeans comprises at least one bottle containing a treatment chemical. 3.The extracorporal thermo-therapy apparatus according to claim 2, whereinsaid first supply means comprises a plurality of bottles containingtreatment chemicals.
 4. The extracorporal thermo-therapy apparatusaccording to claim 1, wherein said heating mens comprises a plurality ofinterconnectable heating containers and separate heaters for eachheating container.
 5. The extracorporal thermo-therapy apparatusaccording to claim 1, including a reaction container for treating saidflow of blood after leaving said heating means, and wherein said secondsupply means is connected to said reaction container to add additionalchemicals to said flow of blood in said reactor.
 6. The extracorporalthermo-therapy apparatus according to claim 5, wherein said reactioncontainer includes a plurality of inclined plates and wherein said flowof blood cascades downwardly over said plates so as to becomeoxygenated.
 7. The extracorporal thermo-therapy apparatus according toclaim 5, including a dialysis column for treating said flow of bloodafter it leaves said reactor.
 8. The extracorporal thermo-therapyapparatus according to claim 7, including a monitor for analyzing saidflow of blood after it leaves said dialysis column.
 9. The extracorporalthermo-therapy apparatus according to claim 1, wherein said pumpingmeans is a pump/pulsator device for moving said flow of blood throughsaid flow circuit.